Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure (DEXinPICU)

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sedation

Treatments: Drug: Dexmedetomidine 0.35µg/kg /h; Drug: Dexmedetomidine 0.5µg/kg /h

Study type: Interventional

Funder types: Other

Identifiers

NCT02996058

IRB00008718/00436

Details and patient eligibility

About

Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.

Full description

Critically ill children require sedation for comfort and to facilitate mechanical ventilation and interventions. The ideal sedative agent for use in critically ill children has to be effective and short-acting, of rapid onset of action, lacks active metabolites, does not accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or respiratory adverse effects, and has few drug interactions.

Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.

The only FDA approved indication of dexmedetomidine is sedation of intubated mechanically ventilated adults for less than 24h. However, the literature is full of many research studies that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both adult and pediatric population and proved its safety and effectiveness.

The aim of this study will be to investigate the safety and efficacy of dexmedetomidine in two different doses in sedation for critically ill mechanically ventilated infants with respiratory failure for 72h duration.

Enrollment: 40 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants (1-12 months).
• Respiratory failure/
• Requiring PICU admission and mechanical ventilation up to 72h.

Exclusion criteria

• Significant renal, hepatic, endocrine or metabolic disease.
• 2nd or 3rd degree heart block.
• hypotension or bradycardia (defined as any value outside the normal range from the patient's age).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

DEX I 0.35µg/kg /h

Active Comparator group

Description:

the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale

Treatment:

Drug: Dexmedetomidine 0.35µg/kg /h

DEX II 0.5µg/kg /h

Active Comparator group

Description:

the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale.

Treatment:

Drug: Dexmedetomidine 0.5µg/kg /h